NAVI Amazon Propol by EQ Maxon Corp.

NAVI Amazon Propol by

Drug Labeling and Warnings

NAVI Amazon Propol by is a Otc medication manufactured, distributed, or labeled by EQ Maxon Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAVI AMAZON PROPOL- sodium monofluorophosphate silicon dioxide paste 
EQMAXON Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredients: Silicon Dioxide 16%, Sodium Monofluorophosphate 0.19%

PURPOSE

Purpose: Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years old

INDICATIONS & USAGE

- Supervise children as necessary until being capable of using without supervision

- Instruct children under 6 years old in good brushing and rinsing habits

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Inactive Ingredients: Propolis Extracts, Silica, Chitosan, Sorbitol Solution, Licorice Extracts, Xylitol

DOSAGE & ADMINISTRATION

- Brush teeth twice daily or after each meal as directed by a dentist or doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAVI AMAZON PROPOL 
sodium monofluorophosphate silicon dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55526-0001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.228 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)	3.6 g  in 120 g
GLYCERIN (UNII: PDC6A3C0OX)	6 g  in 120 g
ERYTHRITOL (UNII: RA96B954X6)	0.12 g  in 120 g
XYLITOL (UNII: VCQ006KQ1E)	0.24 g  in 120 g
STEVIOL (UNII: 4741LYX6RT)	0.24 g  in 120 g
CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)	0.12 g  in 120 g
LICORICE (UNII: 61ZBX54883)	0.12 g  in 120 g
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.12 g  in 120 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55526-0001-1	120 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2013	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2013	11/01/2019

Labeler - EQMAXON Corp. (557821534)

Registrant - EQMAXON Corp. (557821534)

Establishment
Name	Address	ID/FEI	Business Operations
EQMAXON Corp.		557821534	manufacture(55526-0001)

Revised: 12/2019

Document Id: 7491eec7-4567-4d4f-ade8-659e0e094f85

34390-5

Set id: 622d4f43-6a97-4990-a239-0ef187d9b365

Version: 2

Effective Time: 20191226

 

EQMAXON Corp.